Comparision of the effectiveness of viscoelastic and balance saline solution during intraocular lens injection on increasing of intraocular pressure after phacoemulsification cataract surgery
Cataract surgery without ophthalmic viscoelastic device (OVD) during Iol injection for prevention of intraocular pressure(IOP) increasing and corneal endothelial loss
Design
In this study 70 cataract patient of khatamolanbia hospital are selected and as simple randomize divided 2 groups of 35 people:group 1 ophthalmic viscoelastic device (OVD) and group 2 balance saline solution( BSS) are used during intraocular lens( IOL) injection.
Settings and conduct
IOP are measured by Goldman tonometer in pre surgery, one week after surgery, one month post surgery. The corneal endothelial of patients assess with specular microscopy. This research is double blind
Participants/Inclusion and exclusion criteria
Inclusion criterion: cataract (ns 2-3+).
Exclusion criteria: history of eye disease; anti-hypertension drug usage
Intervention groups
Group 1 ophthalmic viscoelastic device (OVD) ; and group 2 BSS; are used during intraocular lens( IOL) injection.
Main outcome variables
Decrease possibility of high intraocular pressure(IOP) due to ophthalmic viscoelastic device (OVD) use; low cost; decrease of operation time; endothelial loss
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171122037577N1
Registration date:2018-02-13, 1396/11/24
Registration timing:retrospective
Last update:2018-02-13, 1396/11/24
Update count:0
Registration date
2018-02-13, 1396/11/24
Registrant information
Name
Abbasali Nozari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3501 8376
Email address
nozariaa931@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-05-21, 1395/03/01
Expected recruitment end date
2017-04-19, 1396/01/30
Actual recruitment start date
2016-05-21, 1395/03/01
Actual recruitment end date
2017-04-19, 1396/01/30
Trial completion date
empty
Scientific title
Comparision of the effectiveness of viscoelastic and balance saline solution during intraocular lens injection on increasing of intraocular pressure after phacoemulsification cataract surgery
Public title
Comparision of the effectiveness of viscoelastic and balance saline solution during intraocular lens injection on increasing of intraocular pressure after phacomolsification cataract surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Cataract nuclear sclerosis (NS)2 or 3 +
Decreasing of vision due to cataract
Exclusion criteria:
No ophthalmic disease andophthalmic surgery history
No ophthalmic drugs use history
No anti-hypertension drugs
Age
From 50 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Actual sample size reached:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Randomize method is Simple randomize. Randomization unit is cluster. Cluster of candidate of surgery according to random numbers table are operated with viscoelastic and balance saline solution a month apart. Surgery procedures were recorded in patient file Eexaminer is unaware about surgery procedures was down.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patients aware about surgical procedure. Surgery procedures were recorded inpatient file. Examiner don't aware about surgical procedure during preoperation and post operation examination. The encoded data was refereed to statistician for analyzing. Surgeon and examiner are different.
Placebo
Not used
Assignment
Parallel
Other design features
-
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committe of Mashhad Ferdowsi University of Medical Sciences
Street address
Khatamolanbia Hospital-Gharani Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
91778-99191
Approval date
2016-04-13, 1395/01/25
Ethics committee reference number
IR.MUMS.FM.REC.1394.621
Health conditions studied
1
Description of health condition studied
Cataract
ICD-10 code
H25.1
ICD-10 code description
Age-related incipient cataract
Primary outcomes
1
Description
Intraocular pressure increasing
Timepoint
Intraocular pressure measuring before surgery,1 week and 1 month after surgery
Method of measurement
Goldman tonometer
Secondary outcomes
1
Description
Corneal endothelial cell count
Timepoint
Before surgery and 1 month after surgery
Method of measurement
Speculare microscopy
Intervention groups
1
Description
Intervention group: balance saline solution using during intraocular lens injection
Category
Treatment - Surgery
2
Description
Control group: viscoelastic devise using during intraocular lens injection
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Khatamolanbia hospital
Full name of responsible person
Akbar Derankhshan MD
Street address
Gharani Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9195965919
Phone
+98 51 3728 1400
Fax
+98 51 3728 5293
Email
nozariaa931@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
akbar derakhshan
Street address
Gharani Ave
City
mashhad
Province
Razavi Khorasan
Postal code
9195965919
Phone
+98 51 3728 1402
Fax
+98 51 3728 5293
Email
derakhshana@mums.ac.ir
Grant name
Mashhad university research unit
Grant code / Reference number
28194
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Abbasali Nozari
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Ophthalmology
Street address
Gharani ave،khathamolanbia hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9195965919
Phone
+98 51 3501 8376
Fax
Email
nozariaa931@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Abbasali Nozari
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Ophthalmology
Street address
Gharani ave،khathamolanbia hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9195965919
Phone
+98 51 3501 8376
Fax
Email
nozariaa931@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Abbasali Nozari
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Ophthalmology
Street address
Gharani ave،khathamolanbia hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9195965919
Phone
+98 51 3501 8376
Fax
Email
nozariaa931@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Total data of patients and research result are shareable after undetectabling of patients since 2019
When the data will become available and for how long
From 2019
To whom data/document is available
Researchers of academic centers only
Under which criteria data/document could be used
Clinical and practical usage is okay
From where data/document is obtainable
e-mail:abbasalinz@gmail.com
tel:00989113720971
What processes are involved for a request to access data/document